Qualified Person (QP)

Competitive
Permanent
Dublin
05 Jun 2019
BBBH732521

The Qualified Person's, role involves responsibility for a range of GMP and product release support activities

Qualified Person (QP)- Pharmaceuticals- South Dublin

Do you have a strong understanding of compliance work? Do you have experience with release and simple Quality processes? Do you find it exciting to work with colleagues worldwide? Do you enjoy participating in compliance improvements and transform the way we think about our work?

Job Purpose:

A vacancy exists within the clients Quality Release department for a Qualified Person. The position is a Permanent position. The successful candidate will report to the Quality Release Manager.

Key Responsibilities:

  • The Qualified Person's, role involves responsibility for a range of GMP and product release support activities which can include Quality batch documentation review and control, review and approval of controlled documents including LPR's and SOP's, component material release, quality performance reporting, and support of investigations.
  • Qualified Persons are expected to support and deliver continuous improvements to remove waste and non-value added activities and to employ problem solving tools including root cause analyses and CAPA identification.
  • They make sure that everything is running smoothly and efficiently. It's about focusing on patients, getting the basics right and challenging the status quo.

Education and Experience:

  • You possess a minimum of a Chemistry, Biology, Engineering or equivalent third level degree qualification.
  • With minimum 5 years' experience in Pharma Quality Assurance and 5 years QP release.
  • Strong understanding of pharmaceutical quality processes and systems, manufacturing processes and other support/control systems is desirable.
  • Knowledge and experience working with Competent Authorities on Quality Defects, Recalls.
  • People management experience and openness to taking on a level of coaching with the Release team.
  • You are a demonstrated self-starter with a proactive, hands-on approach, possessing excellent interpersonal, decision-making, team work, and communication skills. They will be capable of delivering to tight and often multiple deadlines in a dynamic, challenging work environment.
  • You are process oriented and continuously seek ways to improve current state.

Morgan McKinley is acting as an Employment Agency in relation to this vacancy.

Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.

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Fiona Durkin's picture
Senior Consultant | Quality & Validation | Dublin & South East
01 6324650 | fdurkin@morganmckinley.ie